Effects of acarbose treatment in Type 2 diabetic patients under dietary training: A multicentre, double-blind, placebo-controlled, 2-year study

This 24-months, placebo-controlled, double-blind, randomised, group compari son study investigated the effect of acarbose vs placebo for improving meta bolic control in patients with Type 2 diabetes under dietary training insuf ficiently controlled by diet alone. Patients randomised to acarbose had the ir dose increased in a stepwise manner to week 5, From week 5 onwards, they received 100 mg three times daily This incremental dosing scheme was match ed in the placebo group. All patients received specialist, intensive, conti nuous dietary training and counselling throughout the 2 yr of the sandy. Of the 74 patients randomised, 60 were included in the per-protocol analysis (28 receiving acarbose; 32 receiving placebo). HbA(1c) was the primary targ et variable. Per-protocol analysis found that, after 24 months, the mean di fference in HbA(1c) relative to baseline value was -1.71+/-1.6% in the acar bose group and -0.82+/-1.1% in the placebo group, End-point values were 6.8 5+/-1.7% in the acarbose group and 7.41+/-1.1% in the placebo group. This d ifference between acarbose and placebo was statistically significant (p=0.0 2), Patients were defined as responders if they did not require additional treatment with an antidiabetic agent during the study The responder rate un der acarbose therapy was 89%, compared with 47% for placebo (p=0.0005), Aca rbose-treated responders improved their HbA(1c) level to 6.45+/-0.82 % afte r 24 months. The efficacy of acarbose was consistent throughout the study; decreasing efficacy was not evident. The results demonstrate the efficacy o f acarbose for improving metabolic control in patients with Type 2 diabetes , even when such patients receive good dietary treatment and counselling. ( C) 1999, Editrice Kurtis.